• Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
• Preparation
• Content
• Maintenance and updates
• Strategy
• What to expect at meetings and in other interactions with FDA
• Regulatory Requirements of Prescription Drug Labeling and Advertising
• Postmarketing Requirements
  

• Regulatory affairs professionals new to the IND/NDA processes
• Clinical research and development professionals
• Biostatisticians
• Basic researchers
• Quality and manufacturing professionals
• Medical writers
• Business professionals
• Project managers

At the conclusion of this activity, participants should be able to:

• Explain the importance of incorporating regulatory strategy into the drug development plan
• Recognize content and format requirements for INDs/NDAs in the Common Technical Document (CTD) Format
• Communicate the requirements for submitting INDs/NDAs and amendments and supplements
• Describe the FDA review processes for evaluating INDs/NDAs
• Define NDA post-approval responsibilities and requirements
• Identify regulatory mechanisms to facilitate and expedite new development
• State how to report adverse events in accordance with current FDA regulations 
• Apply formal meeting principles and practices when interacting with the FDA
• Outline the regulatory requirements for prescription drug labeling and advertising